Drug Approval Package

Aleve Cold & Sinus Tablet (Naproxen Sodium & Pseudoephedrine Hydrochloride Extended-Release)
Company:  Bayer Corporation
Application No.:  21-076
Approval Date: 11/29/1999

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) (PDF)  

• Correspondence (PDF)  

Date created: August 21, 2001

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